Package Leaflet: Information for the User

Alerlisin 10mg Film-Coated Tablets

cetirizine dihydrochloride

Read this leaflet carefully before you start taking this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.

• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What Alerlisin is and what it is used for

2.What you need to know before you start taking Alerlisin

3.How to take Alerlisin

4.Possible side effects

5.Storage of Alerlisin

6.Contents of the pack and additional information

The active ingredient of Alerlisin is cetirizine dihydrochloride.

Alerlisin is an antihistamine medication.

Alerlisin is indicated in adults and children aged 6 years and above for:

• relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• relief of chronic urticaria (idiopathic chronic urticaria).

Do not take Alerlisin

-if you have a severe kidney disease (severe renal insufficiency with a creatinine clearance below 10ml/min);

• if you are allergic to the active ingredient, to any of the other components of this medication (including in section 6), to hydroxyzine or to piperazine derivatives (closely related active principles of other drugs).

Do not take Alerlisin 10mg film-coated tablets:

• if you have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alerlisin

• if you are a patient with renal insufficiency, consult your doctor; if necessary, you will take a lower dose. Your doctor will determine the new dose.

• if you are an epileptic patient or a patient at risk of seizures, consult your doctor.

No significant interactions have been observed between alcohol (with a blood level of 0.5per thousand, corresponding to a glass of wine) and the use of cetirizine at normal doses. However, as with all antihistamines, it is recommended to avoid the joint consumption of alcohol during treatment.

Children

This medication is not recommended for use in children under 6 years, as this formulation does not allow for appropriate dose adjustments.

Taking Alerlisin with othermedications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

Due to the profile of cetirizine, no interactions with other drugs are expected.

Taking Alerlisin with food and drinks

Food does not significantly affect the degree of absorption of cetirizine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

As with other medications, the use of Alerlisin should be avoided in pregnant women. Accidental use of the medication in pregnant women should not cause any harmful effects on the fetus. However, treatment with the medication should be interrupted.

Do not take Alerlisin during breastfeeding, as cetirizine is excreted in breast milk.

Driving and operating machinery

Clinical studies have not shown evidence that Alerlisin produces attention alterations, reaction capacity decrease, and ability to drive at the recommended dose.

However, if you intend to drive, perform potentially hazardous activities or use machinery, do not exceed the recommended dose. You must observe your response to the medication closely.

If you are a sensitive patient, you may find that the simultaneous use of alcohol or other central nervous system depressants affects your attention and reaction capacity in addition.

Alerlisin contains lactose

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The tablets must be swallowed with a glass of liquid.

Adults and adolescents over 12 years old

10 mg once a day as 1 tablet.

Use in children between 6 and 12 years old

5 mg twice a day, as half a tablet twice a day.

Patients with moderate to severe renal insufficiency

It is recommended that patients with moderate renal insufficiency take 5 mg once a day.

If you notice that the effect of Alerlisin is too weak or too strong, consult your doctor.

Treatment duration

The duration of treatment depends on the type, duration, and course of your discomfort and will be determined by your doctor.

If you take more Alerlisin than you should

After an overdose, the following adverse effects may occur with greater intensity. Adverse effects reported include confusion, diarrhea, dizziness, fatigue, headache, weakness, dilated pupil, tingling, irritation, sedation, drowsiness, stupor, abnormal increase in heart rate, tremor, and urinary retention.

Inform your doctor if you think you have taken an overdose of Alerlisin.

Your doctor will then decide what measures should be taken.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Alerlisin

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Alerlisin

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects have been reported in post-marketing experience:

Frequent: may affect up to 1 in 10 people

• Fatigue
• Diarrhea, dry mouth, nausea
• Dizziness, headache
• Somnolence
• Pharyngitis, rhinitis

Infrequent: may affect up to 1 in 100 people

• Abdominal pain
• Asthenia (extreme fatigue), malaise
• Paresthesia (abnormal skin sensation)
• Agitation
• Pruritus, urticaria

Rare:may affect up to 1 in 1,000 people

• Tachycardia (heart beats too quickly)
• Edema (swelling)
• Allergic reactions, some severe (very rare)
• Abnormal liver function
• Weight gain
• Seizures, movement disorders
• Aggression, confusion, depression, hallucination, insomnia
• Urticaria

Very rare:may affect up to 1 in 10,000 people

• Thrombocytopenia (low platelet count in blood)
• Visual disturbances, blurred vision, nystagmus (eyes have an uncontrolled circular movement)
• Syncope, tremor, dysgeusia (taste disorder)
• Tic
• Abnormal urination
• Edema, drug-induced rash

At the first signs of hypersensitivity, stop taking Alerlisin.

Your doctor will evaluate the severity and decide on the necessary measures.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly to theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es.By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reachof children.

Do not use this medication after the expiration date that appears on the packaging and the blister pack after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alerlisin

• The active ingredient is cetirizine dihydrochloride. Each coated tablet contains 10mg of cetirizine dihydrochloride.
• The other components are:
• Core: microcrystalline cellulose, lactose monohydrate, magnesium stearate, anhydrous colloidal silica.
• Coating: hypromellose (E-464), macrogol 400, titanium dioxide (E-171).

Appearance of the product and contents of the package

Coated tablets with a film coating, white, oblong, scored, and with the Y-Y logo.

Package with 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, or 100tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

RETRAIN, S.A.U.

Alfons XII, 587– 08918 Badalona (Barcelona) – Spain

Responsible for Manufacturing

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 – 08918 Badalona (Barcelona) – Spain

For further information about this medication, please contact the local representative of the marketing authorization holder:

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 – 08918 Badalona (Barcelona) – Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Austria: Zyrtec 10 mg - Filmtabletten

Belgium: Reactine, Cetirizine-UCB, Zyrtec

Bulgaria: Zyrtec

Cyprus: Zyrtec

Czech Republic: Zyrtec, Reactine

Denmark: Benaday, Zyrtec

Estonia: Zyrtec

Finland: Zyrtec

France: Reactine 10mg comprimé pelliculé sécable, Virlix, Cetirizine UCB 10mg, Zyrtec, Actifed Allergie cetirizine10 mg comprimé pelliculé sécable, Zyrtecset

Germany: Zyrtec, Zyrtec P, Reactine

Greece: Ziptek

Hungary: Zyrtec filmtabletta, Zyrtec start filmtabletta

Ireland: Zirtek tablets, Reactine 10mg tablets

Italy: Formistin, Reactidiem “10mg compresse rivestite con film”, Zirtec 10mg compresse rivestite con film

Latvia: Zyrtec

Lithuania: Zyrtec

Luxembourg: Reactine, Zyrtec, Cetirizine-UCB

Malta: Zyrtec

Netherlands: Reactine tabletten 10mg, Zyrtec

Norway: Reactine, Zyrtec

Poland: Reactine, Virlix, Zyrtec, Zyrtec UCB

Portugal: Zyrtec, Virlix

Romania: Zyrtec

Slovakia: Zyrtec tbl flm 10mg, Reactine 10mg

Slovenia: Zyrtec 10mg filmsko oblozone tablete

Spain: Alerlisin, Virlix, Reactine 10mg comprimidos, Zyrtec comprimidos recubiertos con película

Sweden: Zyrlex

United Kingdom: Benadryl one a day, Benadryl one a day relief, Zirtek allergy relief tablets, Zirtek allergy tablets

Last review date of this leaflet: January 2020

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/